The UK, Ireland, Sweden, Holland and Finland want to adopt the directive as it is now written, warts and all, under the assumption that this is as good as it will get and that it shouldbe passed before it is watered down even further.
But even if adopted as is, the directive will virtually clear the shelves of most UK, Dutch and Irish supplements, which contain potencies close to or at the USLs.
The UK's National Association of Health Stores worries that the Commission will extend the definition of food supplements to include ingredients other than just 'concentrated nutrients'. It may mean that a substance such as pycnogenol, which is not approved by the Novel Foods Commission, will no longer be allowed to be sold.
The directive is now under consideration by the Environment Committee of the European Parliament. Amendments to the report will be considered at a meeting of the Committee sometime during the week of 22 January 2001. A resulting report will then be sent for consideration by the entire European Parliament at its plenary session in February.
If the directive is adopted, the intended timetable is that member states will pass laws so that products complying with the directive may be sold after 1 June 2002. All products which do not comply will be banned after 1 June 2004.
Traditional Medicines Directive
Vitamins are not the only supplements that Europe has its sights on. At the moment, a directive has been drafted, largely driven by the UK's Medicines Control Agency (MCA), to create a Europe wide regulation for traditional medicines such as herbs. At this time, the directive has no formal status, but its future is likely to be determined within the next few months.
At the moment, every member state of the EU controls herbal products in a different way. Indeed, 13 of the 15 countries already contravene the European Medicines Directive (65/65).
The Traditional Medicines Directive currently would allow each member state individuality but, eventually, there would be moves to harmonise.
The crux of this directive is that herbs must be 'registered'. To become registered, the manufacturers of such a product must submit reasons for its authorisation within the member state; "expert evidence" (which is never defined) must show that the product, or a similar one, has been in use for a period of at least 30 years before the date of the application.
In a wonderful demonstration of the absurdity of bureaucracy, the directive allows a product a licence if it has been used for 25 years outside the EU and then for five years in one member state. The important criterion is that its use adds up to an aggregate of 30 years.
Any new herbal remedies presumably would be banned, unless they can be shown to be in use in territories outside the EU or in another member state for at least 30 years. This means that new, promising herbal products cannot get a registration.
There are a few exceptions to this, but the product must be part of a certain classification.
The biggest obstacle is what is required of any manufacturer in order to register a product to Europe's satisfaction. A manufacturer must provide a host of detail about its product, including active ingredients and constituents, pharmacokinetic particulars (which is not absolutely essential), contraindications, interactions with other medications, overdose levels and shelf life. In the view of the National Association of Health Stores, these requirements are well beyond the financial capabilities of all but the largest companies.